Drug Approval Package

Azor (amlodipine and olmesartan medoxomil) 5/20, 5/40, 10/20, and 10/40 mg Tablets
Company: Daiichi Sankyo, Inc.
Application No.: 022100
Approval Date: 9/26/2007

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: December 17, 2009

Back to Top    Drugs@FDA

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.